Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06325800

The Role of Glycoxidation on Arterial Biomechanics and Target Organ Damage in Patients With Moderate to High Cardiovascular Risk. The GlycOxiTod Observational Multicentric Registry

Led by Complejo Hospitalario Universitario de Santiago · Updated on 2024-04-09

500

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

C

Complejo Hospitalario Universitario de Santiago

Lead Sponsor

I

Instituto de Investigación Sanitaria de Santiago de Compostela

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand the role of glycation and glycoxidation on arterial biomechanics and target organ damage (TOD) in patients with moderate to high cardiovascular risk who do not have diabetes or established cardiovascular disease. The study focuses on how these biochemical processes affect the structure and function of arteries, and their connection to vascular aging and damage, which are precursors to cardiovascular disease. Researchers will observe these relationships in apparently healthy individuals over time to better comprehend cardiovascular risk progression. This is an observational, multicenter study involving patients over 18 years old who have moderate to high cardiovascular risk but do not smoke or have diabetes. Participants will undergo detailed clinical assessments including ultrasound examinations of carotid and limb arteries to measure arterial stiffness, thickness, flow, and other biomechanical properties. Blood and urine samples will be collected to assess markers of glycation, glycoxidation, oxidative stress, and antioxidant enzyme activity. Skin autofluorescence measurements will estimate advanced glycation end products. The study will track these markers alongside vascular health indicators over a five-year follow-up period. Participants will have initial clinical, anthropometric, and vascular assessments along with laboratory tests in a single visit. Follow-up evaluations will occur annually and at the end of five years to monitor changes in arterial biomechanics, target organ damage, and cardiovascular outcomes such as events or hospitalizations. Retinal imaging will assess microvascular damage. The study will use statistical and mathematical modeling to analyze associations between glycation status, antioxidant activity, arterial health, and cardiovascular risk. This approach will help identify early markers of vascular damage and potential targets for intervention.

CONDITIONS

Brief Title

Glycoxidation, Arterial Biomechanics, and Target Organ Damage

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Moderate to high Cardiovascular Risk estimated by SCORE2OP
  • Signed written consent for participation in the study
Not Eligible

You will not qualify if you...

  • Current smoking habit or smoking within the last 6 months
  • High-risk alcohol consumption (More than 10 g/day for women and 20 g/day for men)
  • Presence of Diabetes mellitus
  • Established cardiovascular disease, including heart failure, ischemic heart disease, valvular heart disease, atrial fibrillation, peripheral artery disease, and cerebrovascular disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and consent

Initial Assessment

Duration - 1 day

Participants undergo a comprehensive clinical-anthropometric evaluation, arterial biomechanics measurements, target organ damage detection, and sample collection in a single medical act.

1 visit (in-person) for all baseline assessments and sample collection

5-Year Follow-up Monitoring

Duration - 5 years

Participants are followed for 5 years with annual and final evaluations of arterial biomechanics, target organ damage, oxidative stress, glycation, glycoxidation markers, and cardiovascular outcomes to assess progression and risk.

Annual visits plus 1 final visit at 5 years

Trial Site Locations

Total: 1 location

1

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain, 15706

Actively Recruiting

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Research Team

N

Nestor Vazquez-Agra, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Metformin and/or vildagliptin mitigate type II diabetes mellitus induced-oxidative stress: The intriguing effect.

Hayder M Al-Kuraishy, Oula Mohamed Sami, Nawar R Hussain...

https://pubmed.ncbi.nlm.nih.gov/33102198

Roles of the lipid peroxidation product 4-hydroxynonenal in obesity, the metabolic syndrome, and associated vascular and neurodegenerative disorders.

Mark P Mattson

https://pubmed.ncbi.nlm.nih.gov/19622391

Alcohol consumption and the risk of hypertension in men and women: a systematic review and meta-analysis.

Alexandros Briasoulis, Vikram Agarwal, Franz H Messerli

https://pubmed.ncbi.nlm.nih.gov/23126352